Scientist III, Analytical Development and Clinical QC

As a Scientist II in Analytical Development and Clinical QC at Alexion, you'll be at the forefront of our Late-Stage Analytical team! This pivotal role demands analytical expertise and a proven track record in managing analytical development projects throughout the CMC lifecycle. You'll prioritize multiple projects, collaborating closely with PDCS teams, Regulatory, QA, and external QC laboratories.

Develop and implement late-stage analytical strategies, including method transfer, validation, and verification, while authoring regulatory filings with a keen understanding of country-specific requirements. As the analytical functional lead for clinical CMC programs, you'll drive end-to-end analytical activities from Phase 3 through commercialization.AccountabilitiesLead all aspects of analytical method validations, transfers, and compendia method verifications across all stages of clinical development and method life-cycle stages.Serve as the analytical lead for CMC programs, focusing on late-stage programs with rigorous cross-functional collaboration.Develop and implement an analytical end-to-end strategy for key late-stage biologics programs, including control strategy, lifecycle management, and QC testing oversight.Lead all aspects of analytical QC testing, troubleshooting issues, and conduct data analysis to ensure program health and identify potential risks.Author regulatory submissions for clinical and commercial markets, addressing health authority queries and requests for information.Essential Skills/ExperienceAdvanced degree (PhD or MSc) in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field4+ years of progressive experience in biologics analytical development across clinical and commercial stages.Proven hands-on strategic and technical expertise with monoclonal antibodies, bispecific, fusion proteins.Technical expertise in chromatography (e.g., SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding, potency), and residuals/impurities testing (HCP, DNA, residual Protein A)Compendia method experience with a focus on USP, EP and JP complianceStrong written and verbal skills for clear reports, regulatory submissions, and presentations to technical and non-technical collaboratorsDemonstrated success in method development, qualification/validation (per ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies.Strong command of ICH (Q5E, Q6B, Q8-Q12), USP/EP, FDA/EMA expectations for biologics, GMP/GLP compliance, and authoring/reviewing CTD Module 3, IND/IMPD, BLA/MAA analytical sections and responses to agency queries.Proficiency with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readinessAbility to define critical quality attributes (CQAs build specifications, and implement commercial control strategies aligned with Quality by Design (QbD)The duties of this role are generally conducted in a lab environment.

As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.Agility / Adapatability (Changing direction as conditions shift) (reframing and pivoting, abandoning outdated approaches)Learning Mindset (Learning, unlearning, and applying quickly) (Curiosity & feedback-seeking, transfer of learning, self-directed, growth mindset independent of role)Agency (Taking ownership and driving action without waiting for instruction - making things happen) (Proactively identifying pr